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Masks and N95 RespiratorsOn this page:
About surgical masks and surgical N95 respiratorsSurgical masks and surgical N95 respirators are disposable devices that cover the mouth and nose during medical procedures. They help protect the caregiver and patient against microorganisms, body fluids, and small particles in the air. Surgical masks and surgical N95 respirators are regulated by the Food and Drug Administration (FDA). FDA evaluates the performance of these devices in areas including fluid resistance and filtration efficiency to ensure that they are at least as safe and effective as similar devices already on the market. FDA encourages manufacturers to follow specific performance standards for their masks, and FDA also requires that these products be produced using good manufacturing practices. Respirators may also be certified by NIOSH (the National Institute for Occupational Safety and Health) in accordance with regulations in 42 CFR part 84. When a mask is both cleared by FDA as a surgical mask and certified by NIOSH as an N95 respirator mask, FDA calls it a "surgical N95 respirator." For more information, see FDA’s Role in Regulating PPE. When to use surgical masks and surgical N95 respiratorsUse surgical masks and surgical N95 respirators to cover your mouth and nose when you may be splattered by or exposed to someone else’s body fluids (such as blood, respiratory secretions, vomit, urine or feces). Types of masks and respirators used in patient careSurgical masks
Surgical N95 respirators
Choosing between surgical masks and surgical N95 respiratorsCDC recommends the use of surgical masks or surgical N95 respirators based on the ways that specific diseases are transmitted. For more information about CDC recommendations, see Infection Control in Healthcare Settings.
Non-medical respiratorsFDA regulates as devices those respirators and other articles that are intended for use in preventing or treating infectious disease. There are a variety of respirators available for various occupational exposures that do not make medical claims and are not regulated by FDA. Many of these respirators are intended to filter out particles of dust and mist from wood, metal, and masonry work. Non-medical respirators are available from many sources including hardware stores and online. Non-medical respirators may look very similar to one another and to respirators that are regulated by FDA. However, there are differences among these respirators and between these non-medical respirators and respirators that have been cleared by FDA as surgical N95 respirators. Only respirators that have passed specific testing by NIOSH may be labeled as NIOSH-certified. Each NIOSH-certified respirator contains a rating, such as N95, which refers to its certified level of filtration efficiency. If a non-medical respirator is not labeled as NIOSH-certified, it has not been evaluated by the government to determine whether or not it works. Although NIOSH-certified nonmedical respirators have met filtration efficiency requirements, they are not subject to the additional requirements of FDA-cleared surgical N95 respirators (i.e. fluid and flammability resistance). What you should know before using surgical masks and surgical N95 respirators
Find all FDA-cleared surgical masks and surgical N95 respiratorsFDA’s website lets you search for medical devices that FDA has cleared or approved, including personal protective equipment. Updated February 28, 2008 |
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